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復宏漢霖-B(02696.HK)向Accord US授予HLX02注射用曲妥珠單抗於美國和加拿大獨家開發與商業化權益
格隆匯 09-30 17:12

格隆匯9月30日丨復宏漢霖-B(02696.HK)公佈,公司已於近日與Accord Healthcare Inc. (Accord US) 訂立一份具約束力條款概要,據此,公司同意向Accord US授予一項許可,供其於美國及加拿大開發及商業化HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優;歐盟商品名:Zercepac)。

許可產品在區域內的許可總里程碑付款包括:首付款2700萬美元,於簽署用於規範該安排的正式協議後支付;監管里程碑付款合計不超過1300萬美元,根據許可產品在美國內的藥物代謝動力學研究進度及上市申請進度支付;及於區域內許可產品商業化後,商業銷售里程碑付款2500萬美元,於許可產品在區域內每取得5億美元的累計淨銷售額時支付。被許可方亦將根據許可產品年度淨利潤的水準向許可方支付許可產品淨利潤的18%至50%的分層特許權使用費。

截至本公告日期,公司已與多個合作伙伴(包括Accord Healthcare Limited、雅各臣藥業(香港)有限公司、Cipla Limited及Mabxience Research,S.L.)就HLX02訂立許可及商業化協議,以便成功於中國境外(包括中國香港、中國澳門、馬來西亞、澳洲、紐西蘭、哥倫比亞、阿根廷、烏拉圭、巴拉圭,以及歐洲、中東-北非及獨聯體等80多個司法權區及地區)進行HLX02的商業化。

據悉,Accord US與Accord Healthcare Limited(集團就HLX02注射用曲妥珠單抗於歐盟等地區的合作伙伴)同為Intas的附屬公司。Accord US於2005年在美國註冊成立,專注於醫院市場領域,且聚焦於腫瘤學、中樞神經和其他重症監護領域,目前已獲得129項仿製藥批准。Intas成立於1976年,總部位於印度,主要從事全球範圍內的藥物製劑成品、活性藥物成分、醫療器械和醫療用品的製造、營銷、分銷及銷售。

公司表示,集團已就HLX02注射用曲妥珠單抗於歐盟等地區商業化與Accord Healthcare Limited建立良好合作關係。本次與Accord US就HLX02注射用曲妥珠單抗於美國和加拿大的商業化合作將有助於進一步推進HLX02注射用曲妥珠單抗海外市場拓展,並加強集團產品的可及性和國際影響力。

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